Performa® 00884450010952Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Performa (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450010952), received between Feb 8, 2022 and Feb 8, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2022Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE DEVICE GOT CAUGHT WHILE ATTEMPTING TO PASS A STENOSIS WITHIN THE RIGHT LEG OF THE PATIENT. WHEN RETRACTING THE CATHETER, THE TIP CAME LOOSE AND REMAINED WITHIN THE VESSEL. ATTEMPTS WERE MADE TO REMOVE THE DETACHED TIP, BUT FAILED AND THE TIP REMAINED IN THE PATIENT. A BYPASS WAS PERFORMED BY THE SURGEON. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 13483663 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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